Medical experimentation "refers
to relatively untested and usually more innovative medical and surgical
procedures which…are applied…primarily as a means of contributing to the
common good in the interests of humanity through anticipated progress in medical
science." (1) A procedure is deemed experimental "because it has not
been accepted by the medical community as a standard treatment for a specific
disease or disorder, or for a subclass of patients, e.g., infants, the
elderly." (2)

Policy

In the case of the dying patient, it is
permissible to undertake experimental procedures which may carry a risk of harm,
provided that other effective treatments are not available and that free and
informed consent is obtained.

It is also permissible to withdraw these
procedures if the investment of resources proves disproportionate to the results
or if the burdens imposed on the patient prove disproportionate to the benefits
gained by him/her, provided that free and informed consent for withdrawal is
obtained.

Sources of Policy

The
basic position was articulated by Pius XII in an address to the World Medical
Association in 1954:

In desperate cases when a patient is certain to die unless his case
is given due attention, and there exists a remedy, a treatment, an operation
which, without precluding all danger, nonetheless retains a certain possibility
of success, a just and thoughtful person acknowledges without further discussion
that a doctor may, with the explicit or tacit consent of the patient, proceed
with application of the treatment. (3)

This
position was reiterated and further developed in the Vatican Declaration on Euthanasia (1980):

If there are no other sufficient remedies, it is permitted, with
the patient's consent, to have recourse to the means provided by the most
advanced medical techniques, even if these means are still at the experimental
stage and are not without a certain risk. By accepting them, the patient can
even show generosity in the service of humanity.

It is also permitted, with the patient's consent, to interrupt
these means, where the results fall short of expectations. But for such a
decision to be made, account will have to be taken of the reasonable wishes of
the patient's family, as also of the advice of the doctors who are specially
competent in the matter. The latter may in particular judge that the investment
in instruments and personnel is disproportionate to the results foreseen; they
may also judge that the techniques applied impose on the patient strain or
suffering out of proportion with the benefits which he or she may gain from such
techniques. (4)

The
Ethical and Religious Directives for
Catholic Health Care Services reaffirms the requirement of free and informed
consent:

No
one should be the subject of medical or genetic experimentation, even if it is
therapeutic, unless the person or surrogate first has given free and informed
consent.In instances of
nontherapeutic experimentation, the surrogate can give this consent only if the
experiment entails no significant risk to the person's well-being.Moreover, the greater the person's incompetency and vulnerability, the
greater the reasons must be to perform any medical experimentation, especially
nontherapeutic. (no. 31)

3.
Pius XII, "Moral Problems in Medicine," Allocution to the Eighth
Congress of the World Medical Association, Sept. 30, 1954 in The
Human Body: Papal Teachings (Boston: Daughters of St. Paul, 1960), p. 314.
See also Pius XII, "The Intangibility of the Human Person" in The
Human Body: Papal Teachings, p. 207.

4.
Congregation for the Doctrine of the Faith, Declaration
on Euthanasia IV (Washington, D.C.: United States Catholic Conference,
1980), p. 9.

In
medical research and experimentation it is mandatory to seek free
and informed consent for use of an experimental procedure. (For a discussion
of informed consent, see the entry
MEDICAL RESEARCH AND EXPERIMENTATION ON HUMAN SUBJECTS: GENERAL PRINCIPLES,
Commentary, "Principles Found in Ecclesiastical Statements," no. 4.)
If the patient is competent, he/she
properly gives or withholds consent. Thus Pius XII speaks of the "consent
of the patient" (1) as does the Vatican Declaration
on Euthanasia (2). However, in the case of a patient who is not able to give
consent (e.g., an incapacitated adult, a child), it falls to an appropriate
proxy decisionmaker to give or withhold consent. (For further discussion of
proxy decisionmaking in the context of medical research and experimentation, see
the entry MEDICAL RESEARCH AND EXPERIMENTATION ON HUMAN SUBJECTS: GENERAL
PRINCIPLES, Commentary; "Principles Found in Ecclesiastical
Statements," no. 4.)In the
treatment of dying adults who are incapacitated, one should ascertain if a proxy
decisionmaker has been legally appointed through the execution of a durable
power of attorney for health care. (See entry ADVANCE
DIRECTIVES:THE LIVING WILL AND
DURABLE POWER OF ATTORNEY FOR HEALTH CARE.)

Some
healthcare professionals and patients have the impression that once a treatment
is initiated, it cannot be stopped or withdrawn. This is incorrect. The Vatican Declaration
on Euthanasia makes explicit two conditions under which experimental
treatments in particular can be stopped: if the investment of resources proves
disproportionate to the result or if the burdens imposed on the patient prove
disproportionate to the benefits gained by him/her. The second condition uses
the principle of weighing benefits and burdens, the standard principle for
making decisions about using or forgoing life-sustaining treatments. (See the
entryGENERAL POLICY ON THE USE OF
LIFE-SUSTAINING TREATMENTS.) This second condition views the experiment from the
perspective of the patient undergoing the treatment, since it is the patient (or
his/her proxy decisionmaker) who must assess the benefits and burdens of a
treatment. The first condition, on the other hand, represents the more objective
perspective of the researcher, but also involves a concept of proportionality.

Withdrawal
from an experiment is also a recognized part of informed consent. (See the entry
MEDICAL RESEARCH AND EXPERIMENTATION ON HUMAN SUBJECTS: GENERAL
PRINCIPLES, Commentary, "Principles Found in Ecclesiastical
Statements," no. 4.)

A
distinction is made between therapeutic and
nontherapeutic research and
experimentation.Research and
experimentation is considered therapeutic
if it holds out a reasonable expectation of improving the health status of the
patient-subject.Research and
experimentationis classified as nontherapeutic
if it is not expected to improve the health of the patient-subject, but will
yield information and knowledge which will benefit other people. (3)The statement of Pius XII that "In desperate cases when a patient is
certain to die unless his case is given due attention, and there exists a remedy, a treatment, an operation which...retains a
certain possibility of success..." (italics added), suggests the use of
experimental procedures which would be therapeutic for the patient.However, unlike the case of experimental procedures on living embryos and
fetuses, the Ethical and Religious Directives for Catholic Health Care Services does
not explicitly rule out the participation of the dying in experiments of
a nontherapeutic nature. (4)In
fact, the Directives do address the
case of proxy consent for nontherapeutic experimentation (5), and some cases of
nontherapeutic experimentation on the dying could fall under this category.

On
the topic of experimental procedures and the dying, see also the entries THE
DISEASE AIDS:ETHICALQUESTIONSANDGUIDELINESWITHRELATEDGOVERNMENTALREGULATIONS,"TreatmentDecisions"andRESEARCHANDEXPERIMENTATION
INVOLVING EMBRYOS AND FETUSES, Commentary.